510(k) K120158 ยท DYB Introducer, Catheter
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS
| Applicant | Thomas Medical Products, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Aug 14, 2012 |
| Received | Jan 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
SafeSheath CSG (Introducer Catheter), REF:
FCL-069-00/A
FCL-069-02/A
FCL-069-03/A
Fo Open, Classified |
DYB | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF:
FCL-083-02/A
WOR-C Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.